1. Technical Field
This invention generally relates to medical appliances and, more particularly, to a device used to control urinary incontinence of a male patient.
2. Discussion
Male urinary incontinence is a long-recognized medical condition which can pose an embarrassment to men whose natural urethral valve or sphincter is no longer capable of controlling the flow of urine from the bladder. Urinary incontinence can arise from a variety of causes, including disease, surgery, neurological dysfunction, malformation of the urethral valve, physical deterioration accompanying advancing age, and other causes. Externally applied absorbent pads and internal catheters connected to collection bags are currently used as solutions to the problem of incontinence. Each of these solutions ultimately entails the external collection of the urine which escapes the bladder. Unfortunately, collection devices such as these can often be uncomfortable, inconvenient, unsanitary, offensive, unreliable and even inadequate during use.
A variety of other devices are known for more actively regulating or controlling male urinary incontinence, rather than merely externally capturing or collecting urine. Some of these other devices include clamps or valves which are surgically implanted, positioned around and compressing the urethra. The clamp or valve is actuated in one way or another to permit the flow of urine through the urethra. These invasive devices have several drawbacks. The most significant of these drawbacks is the risk and cost associated with performing the implant surgery.
Other commonly employed devices for the control of incontinence are non-invasive devices or appliances which include a strap, band, cuff, clamp, cradle, or other member which encircles the penis shaft. A device of this type is positioned about and tightened around the penis shaft until sufficient pressure is applied to the urethra and the corpus spongiosum to substantially or completely close the urethra. The device is loosened or removed to permit the flow of urine through the urethra when appropriate.
A wide variety of non-invasive type devices are known in the art. Such devices can include single or plural members which are flexible or rigid. Some devices include a projection intended to lie beneath the urethra and corpus spongiosum to apply a sealing pressure to the urethra and corpus spongiosum. This projection can be rigid or resilient, or can even be an inflatable sac. This last construction is shown in U.S. Pat. No. 4,800,900 (issued to G. J. French on Jan. 31, 1989, and herein after referred to as the xe2x80x98900 patentxe2x80x99), and is particularly advantageous in that deflation of the sac reduces the pressure applied to the urethra sufficiently to allow urination without requiring removal of the device from the penis shaft.
Devices of the encirclement type usually permit sufficient tightening of the device around the penis shaft to prevent or substantially reduce the leakage of urine through the urethra. Unfortunately, sufficient tightening of the encirclement type device almost universally results in the application of an unacceptable and sometimes painful amount of pressure to tissues other than the urethra and corpus spongiosum. In particular, virtually all devices of this type apply undue pressure to the superficial dorsal vein, the deep dorsal veins, and the dorsal arteries and nerves. This grouping of veins, arteries, and nerves will be referred to as the central dorsal vascular group throughout the present disclosure.
Devices of this general type are often subject to other drawbacks as well. Some are difficult to properly position on the penis shaft. Others are relatively complex in construction, and therefore relatively expensive to manufacture. Some provide poor adjustability to the particular patient using them. Further, wearing many of these devices can be quite uncomfortable, and virtually impossible to withstand for more than a few hours at a time.
In light of the above, a need appears within the industry for a device for controlling male urinary incontinence which avoids applying undue pressure to the superficial dorsal vein, the deep dorsal vein, the lateral superficial veins and the dorsal arteries and nerves of the penis shaft, while ensuring that sufficient pressure is applied to the urethra and the corpus spongiosum to prevent or substantially reduce leakage from the urethra. A need also exists for a device which provides for a relatively precise selection of the dorsally and ventrally applied pressures. The needed device would avoid inflicting pain, trauma and/or damage to the skin and underlying tissues of the penis shaft when used. It would be desirable for such a device to be comfortably worn by the patient for an entire day without removal, except for removal to permit urination. It would further be desirable for such a device to be relatively inexpensive in construction, and relatively easy both to properly position on the penis shaft, and to remove for urination.
The foregoing problems are solved and a technical advance is achieved in an illustrative male urinary incontinence control device which is particularly useful in that it is more comfortable to wear and use than prior devices, yet provides adequate closure of the urethra so as to prevent or substantially reduce leakage of urine through the urethra. The present invention can most simply be considered as an improvement in a strap, band, cuff, clamp or cradle type incontinence control device, the improvement comprising the inclusion of a means (such as a pair of projections or bolsters) which applies pressure preferentially at the specific areas between the lateral superficial veins and the superficial dorsal vein, the deep dorsal vein and the dorsal arteries and nerves. The superficial dorsal vein, the deep dorsal vein and the dorsal arteries and veins can, for practical purposes, be considered comprised within a single group located very near the top center of the dorsal surface of the penis shaft. As previously mentioned, this grouping will be referred to as xe2x80x9cthe central dorsal vascular groupxe2x80x9d. Thus, the control device of the present invention includes a means which applies pressure preferentially at the specific areas between the lateral superficial veins and the central dorsal vascular group.
xe2x80x9cPreferentiallyxe2x80x9d (or xe2x80x9cpreferentialxe2x80x9d) should be understood as meaning that the pressure applied to the penis shaft by the pressure-applying means is greater at these specific areas than the pressure applied elsewhere to the penis shaft, save perhaps for the pressure applied ventrally to the urethra and the corpus spongiosum. The device of the present invention also applies pressure ventrally to the urethra and the corpus spongiosum, however, with the result that the urethra can be closed or substantially closed, while undue pressure on the superficial dorsal vein, the lateral superficial veins, the deep dorsal vein and the dorsal arteries and nerves is avoided. xe2x80x9cSubstantiallyxe2x80x9d means that leakage through the urethra when the device is in place is reduced to as low as about one to six percent of the patient""s daily urine output, typically only about 36 to 75 ml and 20 to 40 ml depending on the embodiment of the device, of a daily outflow of about 1200 to 1500 ml.
This improvement is preferably embodied in a male urinary incontinence control device in which three projections or bolsters are carried on arms of a generally C-shaped resilient member. The words xe2x80x9cprojectionsxe2x80x9d and xe2x80x9cbolstersxe2x80x9d are equivalent for the purposes of the invention, and xe2x80x9cbolstersxe2x80x9d should be understood to be a generic term, encompassing not only xe2x80x9cprojections,xe2x80x9d but also all equivalents of them which extend from the device towards the penis shaft, or which otherwise provide for the preferential application of pressure. The arms of the resilient member are joined by, and preferably unitarily formed with, a spring means. The arms are pivoted towards one another and held in a position by a clip or closure means disposed substantially opposite the spring. Two of the bolsters abut the penis shaft dorsally in the specific areas mentioned above, while the third bolster abuts the penis shaft ventrally at the corpus spongiosum and the urethra. The projections or bolsters are preferably composed of a material softer than or equal to that of the resilient member. Further, the third or ventral bolster can be the inflatable sac (25) disclosed in the ""900 patent, cited above. The entirety of the disclosure of the ""900 patent is expressly incorporated herein by reference.
The present invention is particularly advantageous in that it avoids applying undue pressure to the lateral superficial veins and the central dorsal vascular group while ensuring that sufficient pressure is applied to the urethra and the corpus spongiosum to prevent or substantially reduce leakage through the urethra. Unexpectedly, the positioning of the dorsal pressure-applying means of the control device of the present invention avoids the application of undue pressure to the deep arteries in the corpi cavernosa, even when the applied pressure is sufficient to close or substantially close the urethra. This decreases the risk of discomfort during use of the device of the present invention. The device permits a relatively precise selection of the dorsally and ventrally applied pressures by adjusting the spring means and by correctly selecting the length of the closure means. The present invention substantially reduces or avoids the pain, trauma and/or damage to the skin and underlying tissues of the penis shaft during use when compared to the use of other encirclement type devices. The device of the present invention can be comfortably worn by the patient for an entire day (for example, as much as eighteen hours) without removal, except, of course, for removal to permit urination. The control device of the present invention is relatively inexpensive in construction, and the device is relatively easy both to position properly on the penis shaft, and to remove for urination. Indeed, when the device incorporates a sac similar to the type disclosed in U.S. Pat. No. 4,800,900, the device need not be removed for urination at all.
One aspect the present invention is directed to a male urinary incontinence control device having a first means for applying preferential pressure to the penis shaft at areas between the lateral superficial veins and the central dorsal vascular group, and a second means for applying pressure ventrally to the penis shaft at the urethra and the corpus spongiosum. The second pressure-applying means can simply be the ventral portion of any strap, band, cuff, clamp, cradle or the like which engages the penis shaft and applies pressure for closing the urethra. Preferably, however, the first and second pressure-applying means each comprise an arm carrying on them the projections or bolsters mentioned above. Also, each bolsters of the top can include a slit receiving the associated arm through it, so that the bolsters are movable along the arm on which they are carried. This permits precise fitting of the device to the diameter of the penis shaft of the particular patient wearing it.
Alternatively, the ventral bolster can include an inflatable sac. In such a case, the device of the present invention preferably further includes the valve and syringe assemblies associated with the sac as disclosed in the ""900 patent. Preferably, however, the shape of the sac in the present invention will be somewhat different from the shape shown in the referenced patent. In particular, the sac in the present invention will be relatively longer in one direction (in a direction parallel or transverse to the urethra), and relatively shorter in its other direction.
The dorsal and ventral arms of the first and second pressure-applying means arc preferably unitarily and continuously formed with a spring means which connects them, generally yielding a C-shaped device. Also, the arms and the spring means are preferably formed as a leaf with ramped edges, composed of stainless steel or a medical grade plastic material.
In a second aspect, the present invention is directed to a device of the type disclosed above, and specifically including a particular combination of elements. More particularly, in its second aspect the present invention is directed to a male incontinence control device having a first means for applying preferential pressure to the penis shaft at areas between the lateral superficial veins and the central dorsal vascular group, a second means for applying pressure ventrally to the penis shaft at the urethra and the corpus spongiosum, and a spring means connecting the first and second pressure-applying means. The spring means being unitarily formed with the first and second pressure-applying means, wherein the first pressure-applying means includes a dorsal arm and a pair of dorsal bolsters on the dorsal arm facing the second pressure-applying means, the dorsal bolsters being movable along the dorsal arm, and wherein the second pressure-applying means includes a ventral arm and a ventral bolster on the ventral arm facing the first pressure-applying means. In this aspect, the dorsal and ventral arms of the first and second pressure-applying means, and the spring means, are continuously formed as a C-shaped leaf composed of stainless steel or a plastic, wherein the first pressure-applying means includes a relief means located over the dorsal arteries and nerves, the relief means being a portion of the dorsal arm of the first pressure-applying means spaced away from the dorsal arteries and nerves, and wherein the dorsal bolsters each include a slit through which the dorsal arm is received. The ventral bolster of the second aspect includes either a slit through which the ventral arm is received, or an inflatable sac, and the device further includes a clip connectable to the first and second arms opposite the spring means, the clip limiting movement of the first and second arms away from one another or the penis shaft.
In a further aspect of the invention, a variant off of either aspect mentioned above, the second pressure-applying means is specifically oriented transverse to the penis shaft and urethra. As such, the second pressure-applying means may or may not include a bolster oriented along an arm which carries it.
In still another aspect of the invention, and being another variant of the above mentioned aspects, at least one of the first and second pressure-applying means, comprised of an arm, is of a modified cross-sectional shape. In particular, the cross-sectional shape of at least a portion of the arm is of a modified xe2x80x9cV-shapexe2x80x9d. Notably, the apex or point of the V-shape is toward the penis shaft; when the device is applied thereto.
In yet another aspect, the present invention is directed to an improvement in a strap, band, cuff, clamp or cradle type urinary incontinence control device attachable to the penis shaft and applying pressure ventrally to at least the urethra and corpus spongiosum, the improvement being means on the device for applying preferential pressure to the penis shaft at areas between the lateral superficial veins and the central dorsal vascular group, such that adequate pressure to substantially reduce leakage of urine through the urethra can be applied without unduly interfering with the flow of blood in the penis shaft.
Again, as mentioned above, the incontinence control device of the present invention possesses several significant advantages, most notably that it avoids the undue application of pressure to the lateral superficial vein and the central dorsal vascular group (the superficial dorsal veins, the deep dorsal vein, and the dorsal arteries and nerves) while permitting complete or substantially complete closure of the urethra, thereby comfortably preventing significant leakage of urine from the bladder.